Video: Warning labels don't protect drug makers

WASHINGTON — The Supreme Court forcefully rejected calls Wednesday for limiting consumer lawsuits against drug makers, upholding a $6.7 million jury award to a musician who lost her arm to gangrene following an injection.

The decision is the second this term to reject business groups’ arguments that federal regulation effectively pre-empts consumer complaints under state law.

Diana Levine of Vermont once played the guitar and piano professionally. Her right arm was amputated after she was injected with Phenergan, an anti-nausea medicine made by Wyeth Pharmaceuticals, using a method that brings rapid relief, but with grievous risks if improperly administered.

In a 6-3 decision, the court turned away Wyeth’s claim that federal approval of Phenergan and its warning label should have shielded the company from lawsuits like Levine’s.

“Next to getting my hand back, it’s the best they could do and the least they could have done,” the 63-year-old Levine said. She now plays with one hand and sings.

Levine’s lawsuit said she wasn’t sufficiently warned of the risks of using Phenergan. But Bert Rein, a Washington lawyer who represents Wyeth, said the company’s label complied with federal law.

“Wyeth’s labeling of Phenergan provided clear instructions and warnings about its use, including clear warnings about the very risk at issue in this case,” Rein said.

He said the decision would affect how doctors treat patients. “The practical impact of this is going to be much greater caution” by doctors in deciding whether to use the most effective or least risky method of administering a drug, Rein said.

Wyeth is in the process of being bought by rival Pfizer, Inc., in a $68 billion deal that is expected to close later this year.

The central issue in this case was the absence of language in the federal law setting out regulation of prescription drugs that forecloses consumer complaints in state courts. Congress has included such language in other areas.

“Unless Congress has spoken directly to the question, the court this term has said it is not going to favor broader arguments for pre-emption,” said David Frederick, who represented Levine and the cigarette smokers who won an earlier ruling this term allowing their lawsuits against tobacco companies to proceed.

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The Bush administration and business groups aggressively pushed limits on lawsuits through the doctrine of pre-emption — asserting the primacy of federal regulation over rules that might differ from state to state.

The Supreme Court had largely agreed, ruling last term that FDA approval shields medical devices from most lawsuits. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices.

The Levine case drew a lot of attention because the administration and Wyeth contended that, although the federal Food, Drug and Cosmetic Act lacks a similar provision, drug manufacturers also are protected from most suits over federally approved drugs.

A Vermont jury agreed with Levine’s claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein, a method called “IV push.” Gangrene is likely if the injection accidentally hits an artery — precisely what happened to Levine.

The company appealed and, backed by the Bush administration, argued that once a drug’s warning label gets approval from the Food and Drug Administration, the label can’t be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed.

Justice John Paul Stevens, writing the majority opinion, said Wyeth could “unilaterally strengthen its warning,” especially after it learned of at least 20 incidents before Levine’s injury in which an injection led to gangrene and amputation.

Stevens said he was persuaded that until a recent change by the FDA, the agency “traditionally regarded state law as a complementary form of drug regulation” because it monitors 11,000 drugs.

Justice Clarence Thomas agreed with the outcome of the case, but did not join Stevens’ opinion.

Justice Samuel Alito wrote a dissent that was joined by Chief Justice John Roberts and Justice Antonin Scalia.

“This case illustrates that tragic facts make bad law,” Alito said. “The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.”

The FDA has approved the use of Phenergan by injection, including the method at issue in Levine’s case. The drug has been available for decades to treat nausea and when used properly, both sides agree it is safe and effective.

Stevens said there could be circumstances where consumer lawsuits would not be allowed, including if the FDA had considered and rejected a stronger warning label.

But that was not the case with Phenergan, he said. “As we have discussed, the FDA did not consider and reject a stronger warning against IV-push injection of Phenergan,” Stevens said.

Justice Stephen Breyer agreed in a brief, separate opinion. “It is also possible that state tort law will sometimes interfere with the FDA’s desire to create a drug label containing a specific set of cautions and instructions,” Breyer said.

Rein, the Wyeth lawyer, said he was pleased that the court recognized that some lawsuits could be blocked.

“There are such cases,” he said. “This is not one of them.”

The case is Wyeth v. Levine, 06-1249.

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